Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. Neonates also have an increased amount of CSF and immature myelination 3.

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The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). Session Category: Clinical Research (Excluding Trials). Session Title: Disease-Oriented Innovative Clinical Research and Trials.

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Pharmaceutical Technology

NOVEMBER 24, 2022

Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. Well-planned ADME investigations are conducted in the early stages of clinical research to generate this important data, which is needed for regulatory submissions.

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XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Consider targeting your therapies that fail to be orally bioavailable and brain penetrant. The patients are waiting!

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